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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, nerve
510(k) Number K051718
Device Name NUVASIVE NEUROVISION JJB SYSTEM
Applicant
NUVASIVE, INC.
4545 TOWNE CENTRE COURT
SAN DIEGO,  CA  92121
Applicant Contact LAETITIA COUSIN
Correspondent
NUVASIVE, INC.
4545 TOWNE CENTRE COURT
SAN DIEGO,  CA  92121
Correspondent Contact LAETITIA COUSIN
Regulation Number874.1820
Classification Product Code
ETN  
Subsequent Product Code
GWF  
Date Received06/27/2005
Decision Date 09/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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